JP2024505211A - タンパク質液状製剤及びその製造方法 - Google Patents

タンパク質液状製剤及びその製造方法 Download PDF

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Publication number
JP2024505211A
JP2024505211A JP2023545327A JP2023545327A JP2024505211A JP 2024505211 A JP2024505211 A JP 2024505211A JP 2023545327 A JP2023545327 A JP 2023545327A JP 2023545327 A JP2023545327 A JP 2023545327A JP 2024505211 A JP2024505211 A JP 2024505211A
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Japan
Prior art keywords
efrapegrastim
concentration
liquid
polysorbate
liquid formulation
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Pending
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JP2023545327A
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English (en)
Japanese (ja)
Inventor
キュ リム、ヒョン
ユン キム、サン
ヒ ホン、スン
Original Assignee
ハンミ ファーマシューティカルズ カンパニー リミテッド
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Publication of JP2024505211A publication Critical patent/JP2024505211A/ja
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
JP2023545327A 2021-01-27 2022-01-26 タンパク質液状製剤及びその製造方法 Pending JP2024505211A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020210011802A KR102375269B1 (ko) 2021-01-27 2021-01-27 단백질 액상 제제 및 이의 제조방법
KR10-2021-0011802 2021-01-27
PCT/KR2022/001406 WO2022164204A1 (fr) 2021-01-27 2022-01-26 Formulation liquide de protéine et ses procédés de préparation

Publications (1)

Publication Number Publication Date
JP2024505211A true JP2024505211A (ja) 2024-02-05

Family

ID=80936291

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023545327A Pending JP2024505211A (ja) 2021-01-27 2022-01-26 タンパク質液状製剤及びその製造方法

Country Status (12)

Country Link
US (1) US20240082355A1 (fr)
EP (1) EP4284340A1 (fr)
JP (1) JP2024505211A (fr)
KR (1) KR102375269B1 (fr)
CN (1) CN116782882A (fr)
AR (1) AR124700A1 (fr)
AU (1) AU2022213961A1 (fr)
CA (1) CA3206349A1 (fr)
IL (1) IL304528A (fr)
MX (1) MX2023008804A (fr)
TW (1) TW202231295A (fr)
WO (1) WO2022164204A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100356140B1 (ko) * 1999-07-08 2002-10-19 한미약품공업 주식회사 인간 과립구 콜로니 자극인자 변이체 및 이의 생산 방법
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
EP2525787B1 (fr) * 2010-01-19 2017-03-15 Hanmi Science Co., Ltd. Formulations liquides pour un conjugué de g-csf à action prolongée
WO2013173687A1 (fr) * 2012-05-18 2013-11-21 Genentech, Inc. Formulations d'anticorps monoclonal à concentration élevée
BR112016025126B1 (pt) * 2014-05-07 2024-02-15 Takeda Pharmaceutical Company Limited Composição aquosa compreendendo anticorpo neutralizante de gmcsf, e uso da mesma
KR20200112881A (ko) * 2018-01-24 2020-10-05 비욘드스프링 파마수티컬스, 인코포레이티드. 플리나불린의 투여를 통해 혈소판감소증을 감소시키는 조성물 및 방법
JP2021512121A (ja) * 2018-02-01 2021-05-13 ビヨンドスプリング ファーマシューティカルズ，インコーポレイテッド プリナブリンおよびｇ−ｃｓｆ製剤の投与による化学療法誘発性好中球減少症を軽減するための組成物および方法

Also Published As

Publication number Publication date
EP4284340A1 (fr) 2023-12-06
AR124700A1 (es) 2023-04-26
AU2022213961A1 (en) 2023-08-10
TW202231295A (zh) 2022-08-16
CA3206349A1 (fr) 2022-08-04
IL304528A (en) 2023-09-01
WO2022164204A1 (fr) 2022-08-04
US20240082355A1 (en) 2024-03-14
MX2023008804A (es) 2023-08-04
CN116782882A (zh) 2023-09-19
KR102375269B1 (ko) 2022-03-17

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